A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy
A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy
This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.
Inclusion Criteria:
Exclusion Criteria:
Washington D.C., District of Columbia 20007, United States
Chapel Hill, North Carolina 27599, United States
Fort Worth, Texas 76104, United States
Herston, Queensland 4029, Australia
Vancouver, British Columbia V6Z 2C7, Canada
Tokyo, 162-8655, Japan
Wroclaw, Lower Silesian Voivodeship 50-220, Poland
Lodz-Baluty, Łódź Voivodeship 91-347, Poland
Kemerovo, Kemerovo Oblast 650056, Russia
Krasnoyarsk, Krasnoyarsk Krai 660049, Russia
Saint Petersburg, Leningradskaya Oblast' 190020, Russia
Moscow, Moscow 105275, Russia
Saint Petersburg, Sankt-Peterburg 196645, Russia
Yekaterinburg, Sverdlovsk Oblast 620102, Russia
Kazan', Tatarstan, Respublika 420140, Russia
Cape Town, Western Cape 7925, South Africa
Badalona, Barcelona [Barcelona] 08916, Spain
Brighton, Brighton And Hove BN2 1ES, United Kingdom
London, London, City of SE5 9RJ, United Kingdom